MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00568251
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit push method was attempted to be used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) tube placement procedure performed on (b)(6) 2024.Upon insertion of the peg tube, the plastic part of the peg tube/drain came apart into two pieces outside of the patient.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.During the procedure, peg (percutaneous endoscopic gastrostomy) tube was placed to the patient.Upon insertion, the plastic part of the peg tube/drain came apart into two pieces outside of the patient.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block g2: medwatch reference number: (b)(4).Block h6: imdrf device code a0501 captures the reportable event of peg tube detached.
Additional Manufacturer Narrative
Block g2: medwatch reference number: (b)(4).Block h6: imdrf device code a0501 captures the reportable event of peg tube detached.Block h11: correction block h10: (related report number) has been updated.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit push method was attempted to be used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) tube placement procedure performed on (b)(6) 2024.Upon insertion of the peg tube, the plastic part of the peg tube/drain came apart into two pieces outside of the patient.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.During the procedure, peg (percutaneous endoscopic gastrostomy) tube was placed to the patient.Upon insertion, the plastic part of the peg tube/drain came apart into two pieces outside of the patient.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19714929
• Report Number: 3005099803-2024-03317
• Device Sequence Number: 12890192
• Product Code: KNT
• UDI-Device Identifier: 08714729296805
• UDI-Public: 08714729296805
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2025
• Device Model Number: M00568251
• Device Catalogue Number: 6825
• Device Lot Number: 0032976906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown